CSV ENGINEER

FULL TIME

Dublin, Ireland

Réalta Technologies are searching for a CSV Engineer to support our Pharmaceutical client based in Dublin.

The CSV Engineer will be responsible for leading the development, review, and delivery of automation-related documentation and validation activities. The role requires close collaboration with cross-functional SMEs, equipment vendors, and quality teams to ensure compliance with regulatory standards, project timelines, and operational requirements

Job Responsibilities

Authoring and managing the following (with input from SMEs): C&Q Plan & Risk assessments, Automation Validation Plans, URS documentation / Data Integrity Assessment/ System Impact Assessment / RTMs, FAT/SAT documentation, IOQ documentation and Summary Reports.

Monitor FAT/SAT and IOQ execution activities, proactively identifying protocol execution issues and providing solutions.

Ensure FAT/SAT and IOQ execution aligns with the intent of the test scripts.

Executing tests on lines, systems and equipment that are CSV related.

Ensure all automation deliverables comply with applicable regulations and industry best-practice guidance such as 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.

Maintain consistency and traceability across C&Q Plans, Automation Plans, URS, FAT, SAT, IOQ, STQM/RTM, and Summary Reports.

Identify risks and propose improvements to the C&Q and automation qualification strategy, documentation quality, and test execution strategy.

Share lessons learned and contribute to knowledge transfer for future projects.

Job Requirements

Relevant Computer Science or Engineering degree or equivalent

Minimum of 6 years’ experience in a similar role in life sciences, ideally in pharmaceutical manufacturing.

General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the

E.U. and U.S. FDA.

Expert knowledge of GAMP5.

Strong experience in one or all the following systems: MES, PI Data Historian, PCS, Lab Systems, QBMS, Inspection Line Control Systems, Filling Lines.

Solid technical understanding of computer systems and PLC automation systems, enabling FAT and IOQ protocols to be

authored with support from other SMEs.

Ability to manage multiple deliverables and coordinate with cross-functional resources.

Ability to develop templates for all SDLC deliverables, compliant with client standards, to ensure consistent implementation of the validation strategy, including but not limited to: Requirements Specification, Requirements Traceability Matrix, Functional Specification, Data Integrity Assessments, Design Specification, Code Review and Test specification/test script.

Experienced tester of FAT and IOQ test scripts

Strong interpersonal and communication skills (verbal and written).

Previous experience working with paperless validation system Kneat will be advantageous